智通财经APP讯，石药集团(01093)发布公告，集团开发的化药1类新药SYH2059吸入粉雾剂已获美国食品药品监督管理局(FDA)批准，可在美国开展临床试验。
该产品是集团一款全新的、具有完全自主知识产权的高活性与高选择性磷酸二酯酶4B(PDE4B)抑制剂。本次获得临床试验批准的剂型为吸入粉雾剂。临床前研究显示，该产品可明显提高药物肺部浓度，降低系统暴露，从而降低胃肠道副作用，在疾病动物模型上的药效明显优于现有药物，且具有良好的药代动力学特征和较高的安全窗口。
本次获批的临床适应症为肺纤维化(PF)，包括特发性肺纤维化(IPF)及进展性肺纤维化(PPF)。目前市场上用于治疗该类疾病的药物为数不多，且患者治疗获益有限，该产品有望成为该类疾病的有效治疗药物，具有较大临床开发价值。该产品获得临床试验批准，是集团高端创新吸入技术平台的重要成果，为管线内后续创新吸入制剂的开发奠定了良好基础。
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